Anesthetic Regional Techniques for Vaginal SurgeriesNCT04933500
Regional Anesthesia
An observational study of Anesthetic Regional Techniques for Vaginal Surgeries, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
Trial summary
Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthetic Regional Techniques for Vaginal Surgeries
- What is being tested?
- Whitacre spinal needle
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Dec 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: adult female Egyptian patients
Who may be able to join
- ASA I-II
- --Age(25-55)years
- Height(150-170cm)
Who cannot join
- patient refusal
- severe mitral or aortic stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Dural Puncture Epidural Technique and Conventional Epidural Technique During Elective Gynecological Vaginal Surgeries
Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement.
- Being tested
- Whitacre spinal needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whitacre spinal needleDevice
25G Whitacre spinal needle
| Study group | Role | What they receive |
|---|---|---|
| Conventional epidural | epidural needle: Tuhoy needle 1.3mm (18 G) with 20G multi-orifice epidural catheter | |
| Dural puncture epidural | epidural needle;Tuhoy needle 1.3mm (18G)with 20G multi-orifice epidural catheter and 25G Whitacre spinal needle Receives: Device: Whitacre spinal needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of bilateral sacral sensory loss
sacral sensory loss is observed by needle brick
Measured: 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetic Regional Techniques for Vaginal SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Reham Ali Abdelhaleem Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933500
- Sponsor's protocol ID
- AL-2021
- Status last verified
- Dec 2022
- First submitted
- 16 Jun 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dural Puncture Epidural Technique and Conventional Epidural Technique During Elective Gynecological Vaginal Surgeries
- ClinicalTrials.gov ID
- NCT04933500
- Acronym / sponsor ID
- AL-2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Reham Ali Abdelhaleem AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional epidural | – | –epidural needle: Tuhoy needle 1.3mm (18 G) with 20G multi-orifice epidural catheter |
| Dural puncture epidural | – | Device: Whitacre spinal needleepidural needle;Tuhoy needle 1.3mm (18G)with 20G multi-orifice epidural catheter and 25G Whitacre spinal needle |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult female Egyptian patients
Key inclusion criteria (3 listed)
- ASA I-II
- --Age(25-55)years
- Height(150-170cm)
Key exclusion criteria (2 listed)
- patient refusal
- severe mitral or aortic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whitacre spinal needle25G Whitacre spinal needle | Device | Dural puncture epidural |
Primary outcome
Onset of bilateral sacral sensory loss
Time frame: 4months
sacral sensory loss is observed by needle brick
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthetic Regional Techniques for Vaginal Surgeries, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of bilateral sacral sensory loss (time frame: 4months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.